Cleared Traditional

K051503 - UGYTEX SUAL KNIT MESH

K051503 is the FDA 510(k) clearance for UGYTEX SUAL KNIT MESH by Sofradim Production. It is a Class 3 Obstetrics & Gynecology device (product code OTP) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K051503 · Sofradim Production · Obstetrics & Gynecology device
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Aug 2005
Decision
59d
Days
Class 3
Risk

K051503 is an FDA 510(k) clearance for the UGYTEX SUAL KNIT MESH. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code OTP), Class III - Premarket Approval.

Submitted by Sofradim Production (Ayer, US). The FDA issued a Cleared decision on August 5, 2005 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5980 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K051503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2005
Decision Date August 05, 2005
Days to Decision 59 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 160d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.5980
Definition Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

All 23
Devices cleared under the same product code (OTP) and FDA review panel - the closest regulatory comparables to K051503.
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K063712 · C.R. Bard, Inc. · Mar 2007
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
K063562 · Ethicon, Inc. · Feb 2007
MENTOR NOVASILK MESH
K053414 · Mentor Corp. · Dec 2005
AMS PERIGEE SYSTEM
K040623 · American Medical Systems, Inc. · May 2004
AMS APOGEE VAULT SUSPENSION SYSTEM
K040537 · American Medical Systems, Inc. · Apr 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K040521 · American Medical Systems, Inc. · Mar 2004